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FDA 510(k)

GMK UNI

K-Number: K161741 · 2017-04-14

ApplicantMedacta International S.A.
Decision Date2017-04-14
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMK UNI is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2017-04-14 under 510(k) number K161741. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GMK UNI?

GMK UNI is a medical device that received FDA 510(k) clearance on 2017-04-14. The listed applicant is Medacta International S.A.. The 510(k) number is K161741.

When did GMK UNI receive FDA 510(k) clearance?

GMK UNI received FDA 510(k) clearance on 2017-04-14, under 510(k) number K161741.

Who is the listed applicant for GMK UNI?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GMK UNI?

The FDA product code for GMK UNI is HSX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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